Pharmaceutical compositions rich in omega-3 polyunsaturated fatty acids (PUFAs) have been developed to treat a variety of clinical indications, including various disorders of blood lipids, including hypertriglyceridemia and mixed dyslipidemias. Statin monotherapy is widely used to treat hypercholesterolemia and other blood lipid disorders.
Numerous studies have reported on the increased benefits of combined treatment with statins and omega-3 PUFAs in various cardiovascular disorders (See Nakamura et al., 1999, Int. J. Clin. Lab Res. 29:22-25 and Davidson et al., 1997, Am J Cardiol 80:797-798). To improve patient convenience and compliance, dual compositions comprising statins and omega-3 PUFAs in esterified form have been described, but some statins are known to be poorly soluble in such formulations (see, e.g., U.S. Pat. No. 7,642,287), and no such dual composition is commercially available.
Therefore, there is a need in the art for compositions that combine statins and omega-3 PUFAs in a single oral unit dosage form, and that provide enhanced solubility and bioavailability. Such pharmaceutical compositions would improve patient convenience, and may allow for treatment with improved effectiveness, fewer excipients, and better patient compliance, than is provided by the administration of the two actives in separate unit dosage forms.